International experts speak out against the IOM contract to determine clinical diagnostic criteria

Mary Dimmock reviews a most welcome announcement from our expert clinicians and researchers who have urged HHS to adopt the Canadian Consensus Criteria and save money by cancelling the contract with the Institute of Medicine...

On the same day, 35 of the leading international researchers and clinicians in the field of ME/CFS have written an open letter to Secretary Kathleen Sebelius to announce that they have reached a consensus on adopting the Canadian Consensus Criteria (CCC) as the research and clinical case definition for ME/CFS.

Our experts called for HHS to follow their lead by using the Canadian Consensus Criteria as the sole case definition for ME/CFS in all of HHS’s activities relating to the disease, and strongly urged HHS to abandon its plans to reach out to groups like the Institute of Medicine to develop clinical diagnostic criteria.

Acknowledging that the case definition will be refined as science advances, the authors unambiguously endorsed the CCC as the baseline criteria, stating:

“The expert biomedical community will continue to refine and update the case definition as scientific knowledge advances, for example, this may include consideration of the 2011 ME International Consensus Criteria … As leading researchers and clinicians in the field, however, we are in agreement that there is sufficient evidence and experience to adopt the CCC now for research and clinical purposes, and that failure to do so will significantly impede research and harm patient care.”​

Just as directly, the authors stated their strong opposition to the IOM initiative, stating:

“We strongly urge [HHS] to abandon efforts to reach out to groups such as the Institute of Medicine (IOM) that lack the needed expertise to develop “clinical diagnostic criteria” for ME/CFS. Since the expert ME/CFS scientific and medical community has developed and adopted a case definition for research and clinical purposes, this effort is unnecessary and would waste scarce taxpayer funds that would be much better directed toward funding research on this disease. Worse, this effort threatens to move ME/CFS science backward by engaging non-experts in the development of a case definition for a complex disease about which they are not knowledgeable.”​

Wow! Could our experts have spoken any more clearly, loudly and collectively?

More than any other issue, HHS’ decades long failure to adopt a definition that actually reflects our disease has confounded research and forestalled drug development. It has caused doctors to dismiss their patients’ illness or attribute it to depression. It has bred the widespread stigma and misunderstanding that ME/CFS patients face every day. By its actions, HHS has abandoned ME patients to lives of terrible debility and suffering with no treatments, no care and no hope that anything will ever change. In the face of such suffering, some patients have chosen suicide.

Compounding its mistakes, HHS unilaterally entered into a contract with the Institute of Medicine (IOM) to develop clinical diagnostic criteria and has repeatedly stated its intent to use non-experts to define our disease. We need only look to the Gulf War Illness experience with the IOM and the resulting “Chronic Multisymptom Illness” to know that this would be disastrous.

But today, thanks to our experts, the time for pretending ME/CFS doesn’t exist is OVER! The time for burying this devastating disease inside of an illegitimate collection of unexplained fatiguing illnesses is OVER! To quote advocate Tom Hennessey, “NO MAS!”​

HHS can no longer claim that there is a lack of consensus amongst disease experts. As with every other disease, it is time for HHS to follow the lead of our disease experts and adopt the Canadian Consensus Criteria for research and clinical purposes. In particular, HHS must now stop wasting taxpayer dollars on misguided efforts that, in the words of the letter authors, “threaten to move ME/CFS science backwards.”

For patients who have suffered through years of studies into “false illness beliefs” and maladaptive coping styles, this is finally a way out of the morass, an escape route from all those wasted years. As the authors stated, adopting the CCC will “jump start progress and lead to much more rapid advancement in research and care for ME/CFS patients.” It gives hope that our disease will be treated as the terrible disease that it is and that progress will now come quickly. It gives hope that we will soon rise up from our beds!

This letter is both remarkable and historic for the ME/CFS community

But what does this letter mean in terms of the Institute of Medicine contract that Health and Human Services has just signed? Typically, like most contracts, government contracts have mechanisms built into them to allow the contract to be cancelled when the contract no longer makes sense.

Now that the ME/CFS experts have spoken, the path forward is clear. It does not make sense to waste money and time redefining the disease when the experts have now agreed upon the immediate adoption of the Canadian Consensus Criteria.

We need to send two strong messages to HHS:

First, HHS needs to immediately adopt the CCC as the sole definition for ME/CFS as the experts have called for.

Second, HHS needs to cancel the IOM contract, which is completely unnecessary, wasteful and a step backwards scientifically.

And, we need to forcefully engage our congressional leaders on this issue.

Further information along with the actions to take with congressional leaders will be provided by Mary tomorrow.

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An advisory committee for AIDS at least discussed resigning en masse to protest poor response of the US government. Sorry for the dim memory but I think it was 1991 during a relatively short relapse for me while living on Capitol Hill. I haven't been able to find information on it online. It seems like the name of the woman chairing the committee was something like Dr. Osborn.

Perhaps the CFSAC should consider doing that now after three decades of government screwups and 20+ years of being ignored.

Back then on Capitol Hill I endeavored to be the model of diplomacy in representing the patient community. After seeing what has transpired since then I think we need less diplomacy sometimes and more healthy activists all the time.

Thank you Mary for this very important article!
A special shout out to Russ for working so hard to rush this through

This is huge news.

Since the beginning of this proposed action on August 29th, I have been thinking what are our clinicians thinking about this? Where do they stand? Do they want this action to go through?

The whole world can clearly see their answer. I am so impressed that they have taken time out of their busy lives and worked on this in the background in unity and presented it to the secretary of health.

I have been feeling very dejected about the fact that HHS seemed to follow their agenda no matter what. I know that many of you were excited about HHS' e-mail of yesterday where they state that they have heard us and we will have a voice in the process. Are we going to have the same voice as we have had at CFSAC for the past ten years? We have repeatedly begged them to adopt and recognize the CCC and work from there for the past ten years and what was their answer? "It is too complicated for physicians to follow". I think that the IOM which by the way never in it's experience were charged with creating diagnostic criteria for disease (except currently for GWI), will just give HHS a larger platform to work their agenda.

I was telling a friend yesterday that we really have no leverage when it comes to impressing HHS. All we can do is send e-mails to them and/or congress. Why should they listen? Our leverage has just come in the form of this letter from our physicians and researchers! No one else can know this disease better that the signed 35.

Very pleased to see this, I think it is the correct approach, so well done to them and others behind the scenes who helped organize it. Hopefully we will continue to see more of the same going forward in other important matters.

I was very pleased to see the list of signers--it includes every doctor and researcher I can think of that are in the field--quite a long list. If the government doesn't listen to this, they're fools and obstructionists.

I agree - it's great that our clinicians and researchers have got together to do this. I hope they might become more involved in advocacy as an expert group in future. We desperately need their help and they are uniquely positioned.

wow, great start to my day seeing this letter from all of our wonderful researchers and doctors. I can't wait to see what happens next. Sign me up with any follow through letters we may need to sign and send. Lets put money into research.

I just want to add here that we are in this mess of a crossroads here because HHS did not consult with anyone - not CFSAC, patient advocates nor our clinicians and researchers BEFORE embarking on this "secret" action.

Thank you Mary for this very important article!
A special shout out to Russ for working so hard to rush this through

This is huge news.

Since the beginning of this proposed action on August 29th, I have been thinking what are our clinicians thinking about this? Where do they stand? Do they want this action to go through?

The whole world can clearly see their answer. I am so impressed that they have taken time out of their busy lives and worked on this in the background in unity and presented it to the secretary of health.

I have been feeling very dejected about the fact that HHS seemed to follow their agenda no matter what. I know that many of you were excited about HHS' e-mail of yesterday where they state that they have heard us and we will have a voice in the process. Are we going to have the same voice as we have had at CFSAC for the past ten years? We have repeatedly begged them to adopt and recognize the CCC and work from there for the past ten years and what was their answer? "It is too complicated for physicians to follow". I think that the IOM which by the way never in it's experience were charged with creating diagnostic criteria for disease (except currently for GWI), will just give HHS a larger platform to work their agenda.

I was telling a friend yesterday that we really have no leverage when it comes to impressing HHS. All we can do is send e-mails to them and/or congress. Why should they listen? Our leverage has just come in the form of this letter from our physicians and researchers! No one else can know this disease better that the signed 35.

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Neilk said "Are we going to have the same voice as we have had at CFSAC for the past ten years? We have repeatedly begged them to adopt and recognize the CCC and work from there for the past ten years and what was their answer? "It is too complicated for physicians to follow". I think that the IOM which by the way never in it’s experience were charged with creating diagnostic criteria for disease (except currently for GWI), will just give HHS a larger platform to work their agenda."

My thoughts exactly. My concerns have not changed and now that the experts have spoken, why would HHS pursue this initiative.

So am I reading this correctly?? The IOM contract is still going through but they have to "use a process with stakeholder input, including practicing clinicians and patients" And it's going to take them 18 months to do this? I was hoping that in the next year we would have some huge break through with a medication to help us. And it's going to take them 18 months just to come up with a Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome?

The bright side I guess is that they will collaborate with CFS/ME patients, researchers and clinicians. And have faith they will not do something behind our backs....again.

As I read the letter from HHS announcing the IOM study a few things pissed me off. I didn't like how pleased they are and how they bring up that the study grew out of the 2012 CFSAC recommendation.

We are pleased to announce that the Institute of Medicine (IOM) will begin conducting a study on Diagnostic Criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome this month. I'm so glad they are pleased with themselves after what they put us through and tried to sneak behind our backs.

This study grew out of the 2012 CFSAC recommendation to the Secretary to convene a workshop to “reach a consensus for a case definition useful for research, diagnosis and treatment of ME/CFS.” Because the use of and audience for case definitions for research and clinical care are very different, HHS decided that separate processes were needed to develop them.

This is their way of saying you asked for it. Yes but we didn't ask for them to lie and go behind our backs and choose a definition with out our community being involved.

HHS is proud to be making this investment in ME/CFS. We have heard the advocates’ concerns and trust that many have been addressed by the information provided in this email. It is our hope that a widely accepted clinical definition and a clear distinction from case definitions for clinical trials and research will aid in advancing clinical care, drug development, and basic translational research for ME/CFS.

Now they state how proud they are. Pleased and Proud. Well i'm SICK AND TIRED!!!! I want to trust in them but it's going to be really hard to do.

To all the hardworking cfs/me advocates/patients within our community that push for change and make sure that nothing slips past us.....THANK YOU.

Great news--and all our thanks to the great doctor/researchers who have been doing their best for us for years, and now come up with a strong and united voice that will--we hope--be impossible to ignore. This is real collaboration! Chris

However, the CAA has stopped short of rejecting the IOM contract and endorsing the CCC. They had a huge opportunity to stand beside the researchers and clinicians who said "No. We the experts already solved this problem. Spend the money on research instead of on unqualified people groping around in the dark.". And the organization with Research First as their slogan is supporting the IOM process. Just once I'd like to see a bold statement come from the CAA.

I guess one of the things we have to ask ourselves is how long it is likely to be until any research can lead to an improvement on the CCC. You might say, for example, that if the Rituximab trials work out, then that could blow all existing criteria out of the water; on the other hand if they don't work out - or only do for a minority - and the evidence for ME being an autoimmune disease is not forthcoming: to what degree is the CCC adequate. Is it enough of an improvement on what you have now in the US - the CDC definition - to bring things together and move us forward.

Personally, I am still at a loss to explain the need for a differing clinical and research criteria when we are where we are i.e. with a disease based solely on exclusion of other more demonstrable conditions and symptomology. NICE in the UK when reviewing all the criteria they did - and at the time (mid 2000's) found that the CCC lacked methodology when compared to other criteria. I don't know what process the IOM and DHSS want to apply to their review: but something needs to happen. Something needs to be agreed as a way forward.

The Institue of Medicine, IOM, redefined another illness GWI or GWS which is similar to ME/CFS in 2013. The veterans have a strong lobby in Congress

Even though the IOM stated that these men and women were exposed to biological and chemical toxins, depleted uranium, particulate matter and infectious agents and the IOM acknowledge them as contributors, and it found it found most compelling the scientific evidence that the prime culprits were neurotoxins — in overused insecticides, experimental anti-nerve gas pre-treatment pills, and sarin plumes from the Air Force’s bombing of an Iraqi weapons plant!

The committee evaluated all treatments for which there was evidence, including prescription medicines and alternative therapies. On the basis of the voluminous evidence it reviewed, the IOM committee cannot recommend one single therapy to manage the health of veterans with CMI and, further, rejects a one-size-fitsall treatment approach. Instead, the committee endorses individualized care management plans.

The committee notes that the best available evidence from studies of treatments for CMI and related health conditions demonstrates that veterans who have CMI may benefit from such medications as selective serotonin reuptake inhibitors and serotonin norepinephrine reuptake inhibitors, and from cognitive behavioral therapy, which has been shown to reduce symptoms.

Other interventions and approaches hold promise for treating CMI but lack robust scientific evidence of their effectiveness. For this reason, the VA should fund and conduct studies of interventions, such as biofeedback, acupuncture, St. John’s wort, aerobic exercise, motivational interviewing, and multimodal therapies.

So you now know what the outcome will be for ME/CFS if you don't contact your respresentative! Need I say more?